Bronx MBCT-Migraine

Migraine Clinical Trial

— BMBCT-M  

Official title:

Bronx Mindfulness Based Cognitive Therapy for Migraine: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02443519
• Other study ID #: 2015-4684
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: February 2019

Study information

• Verified date: September 2020
• Source: Albert Einstein College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This randomized clinical trial aims to examine the effect of a standardized 8-week course of Mindfulness Based Cognitive Therapy for Migraine on migraine-related disability in people with migraine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: February 2019
• Est. primary completion date: October 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• ICHD-3 beta headache diagnosis of migraine,

• self-reported and diary-confirmed 4-20 headache days per month

• aged 18-65

• ability to read English

• capacity to consent.

Exclusion Criteria:

• no ICHD-3 beta headache diagnosis of migraine

• fewer than 4 or greater than 20 headache days per month

• under 18 or over 65

• inability to read English

• lacking the capacity to consent

• utilization of new preventative pain treatments within four weeks of the baseline assessment, or a plan to utilize new preventive pain medications during the duration of the study

• severe psychiatric illness that would interfere with participation in the treatment

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Intervention

Behavioral:
• MBCT for Migraine
8 75-90 minute individual sessions of the manualized Mindfulness-based Cognitive Therapy plus a manual and homework

Locations

Country	Name	City	State
United States	Yeshiva University	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Albert Einstein College of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of People With "Severe" Scores on the Migraine Disability Assessment	The MIDAS is a 5-item, self-report instrument that assesses the number of days in the past three months participants experienced partially or fully reduced functioning in a variety of contexts (work, school, social). MIDAS scores are totaled and interpreted in the following grades: 0-5 = Grade I (Little or no disability); 6-10 = Grade II (Mild disability); 11-20 = Grade III (Moderate disability); 21+ = Grade IV (Severe disability). Scores were dichotomized at "Not Severe" (Grades I, II, and III) and "Severe "(Grade IV). The outcome was the proportion of participants who reported "Severe Disability."	Change from Month 1 to Month 4
Primary	Headache-Related Disability Index	25-item, self-report questionnaire of the emotional and functional impact of headache on daily activities. Total scores range from 0-100, with higher scores indicating higher levels of disability.	Change from Month 1 to Month 4
Secondary	Headache Days (Over Course of 1 Month)	Number of headache days/month for the month prior to treatment, and the month after treatment	Change from Month 1 to Month 4
Secondary	Average Headache Severity for Headache Days Recorded Over 30 Days	Headache Severity was recorded for every headache day on a scale of 0 = None, 1 = Mild, 2 = Moderate, 3 = Severe. Average headache severity was averaged across all headache days for each month.	Change from Month 1 to Month 4
Secondary	The Pain Catastrophizing Scale	13-item self-report measure that conveys a participant's level of pain-related, catastrophic thinking during painful experiences. Total scores range from 0-52, with higher scores indicating higher levels of catastrophizing.	Change from Month 1 to Month 4
Secondary	Chronic Pain Acceptance Questionnaire	20-item, self-report measure of pain-related acceptance. Total scores range from 0-156 with higher scores indicating higher pain acceptance.	Change from Month 1 to Month 4
Secondary	Five Facet Mindfulness Questionnaire	39-item self-report instrument assessing mindfulness. Total scores range from 39-195, with higher scores indicating higher levels of mindfulness.	Change from Month 1 to Month 4
Secondary	Headache Specific Locus of Control	33-item measure designed to assess the extent to which individuals with recurrent headaches expect that the occurrence, worsening, and improvement of their headaches are influenced primarily by their own behavior, by chance or fate, or by the actions of medical professionals. Total scores range from 33-165, with higher scores indicating more external (vs. internal) locus of control.	Change from Month 1 to Month 4
Secondary	Headache Management Self-efficacy Scale	25-item self-report scale designed to capture the confidence a patient believes they have in their own abilities to prevent headache episodes and manage their pain. Total scores range from 25-175, with higher scores indicating higher levels of self-efficacy	Change from Month 1 to Month 4
Secondary	NIH PROMIS Depression Short Form	8-item self-report measure that assesses emotional distress in the past week focusing on negative mood and negative self-views. Scores are normed using T-scores (M = 50, SD = 10) with higher scores indicating higher levels of depressive symptoms.	Change from Month 1 to Month 4
Secondary	NIH PROMIS Anxiety Short Form	8-item self-report measure that assesses emotional distress in the past week focusing on fear, worry and hyper-arousal. Scores were normed using T-scores (M = 50, SD = 10) with higher scores indicating higher levels of anxious symptoms.	Change from Month 1 to Month 4
Secondary	Average Monthly Migraine Disability Index	A daily 4-item measure of migraine related disability. Scores range from 0-10, with higher scores indicating higher levels of disability. Scores are averaged across all headache days recorded each month.	Change from Month 1 through Month 4